Device product
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
Z-2967-2018
Product summary
- Event
- Event 80692
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-2967-2018
Official wording
Reason: After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Code information: All. Lots-866A1011, 866A1022
Distribution pattern: U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.
Derived failure modes
-
Unknown
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.